Neogen Handpiece Gry
Neogen Handpiece Gry (830-031) is a nitrogen plasma skin surface treatment system (FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Energist, Ltd., cleared under FDA 510(k) K132754 on 12 Dec 2013 and listed in FDA GUDID since 13 May 2021 (UDI-DI 05060440520129), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05060440520129 | Date13 May 2021 | StatusListed |
| United States | FDA 510(k) | NumberK132754 | Date12 Dec 2013 | StatusActive |
Official records
- AccessGUDID record 05060440520129
- FDA 510(k) database K132754
Across registries
- FDA 510(k) K132754 decided 12 Dec 2013 Active
- FDA GUDID UDI-DI 05060440520129 listed 13 May 2021 Listed
Timeline
- Cleared FDA 510(k) K132754
- Listed FDA GUDID 05060440520129
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Neogen
- Generic name
- Nitrogen plasma skin surface treatment system
- Model / Ref / Catalog
- Handpiece Gry, 830-031
- Primary DI / UDI-DI
- 05060440520129
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Nitrogen plasma skin surface treatment system
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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